IP Library › Granted Patent US 12,740,988
Granted Patent B2
US 12,740,988 · App. 18/251,923 · Granted Sep 22, 2026

Pharmaceutical composition comprising meloxicam

Inventors: Pankaj Devidas Patil (Hyderabad, IN); Vivekanand Khyamgonde (Hyderabad, IN); Ritesh Kakaria (Hyderabad, IN); Ashish Jaiswal (Hyderabad, IN); Akhilesh Dixit (Hyderabad, IN); Santanu Chakraborty (Hyderabad, IN); Amit Antarkar (Hyderabad, IN); Abhijit Deshmukh (Hyderabad, IN); Jeffrey P. Smith (Morgantown, WV)
Assignee: Mylan Laboratories Limited
A61K31/5415A61K9/2009A61K9/2027A61K9/2054A61K9/2081A61K9/5078
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Quick Facts
Patent No.
US 12,740,988
App. No.
18/251,923
Granted
Sep 22, 2026
Kind
B2
Abstract

The present invention relates to novel pharmaceutical composition comprising meloxicam for the treatment of acute pain, wherein the composition comprises at least a hydrophilic polymer and one or more alkalizing agents or combinations thereof.

Claims (22)

1 . A solid oral pharmaceutical tablet for the treatment of acute pain, the tablet comprising amorphous meloxicam and at least one pharmaceutically acceptable excipient, wherein the amorphous meloxicam is embedded in alkaline surroundings comprising one or more water-soluble alkalizing agents, and wherein the tablet provides a Tmax of meloxicam that is less than about 3 hrs in a human subject under fasting conditions.

2 . The solid oral pharmaceutical tablet according to claim 1 , wherein the tablet has rapid drug release with an increased rate of absorption, and wherein the tablet is free of cyclodextrin and its derivatives.

3 . The solid oral pharmaceutical tablet according to claim 2 , wherein the tablet has a dissolution rate of more than 90% by weight within 15 minutes.

4 . The solid oral pharmaceutical tablet according to claim 1 , wherein the tablet comprises about 5 mg to about 50 mg of meloxicam.

5 . The solid oral pharmaceutical tablet according to claim 4 , wherein the tablet comprises about 7.5 mg to about 15 mg of meloxicam.

6 . The solid oral pharmaceutical tablet according to claim 1 , wherein the pharmaceutically acceptable excipient comprises one or more diluents, binders, hydrophilic polymers, lubricants, glidants, disintegrants, water-soluble alkalizing agents, coating materials, solvents or combinations thereof.

7 . The solid oral tablet pharmaceutical according to claim 6 , comprising a hydrophilic polymer or polymers selected from the group consisting of copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose and combinations thereof.

8 . The solid oral pharmaceutical tablet according to claim 7 , wherein the hydrophilic polymer or polymers is copovidone.

9 . The solid oral pharmaceutical tablet according to claim 1 , comprising a water-soluble alkalizing agent or agents selected from the group consisting of sodium carbonate, sodium bicarbonate, meglumine, calcium carbonate and combinations thereof.

10 . The solid oral pharmaceutical tablet according to claim 9 , wherein the water-soluble alkalizing agent or agents is sodium bicarbonate.

11 . The solid oral pharmaceutical tablet according to claim 10 , wherein the sodium bicarbonate is present in an amount of about 100 mg to about 400 mg.

12 . The solid oral pharmaceutical tablet according to claim 11 , wherein the amount of sodium bicarbonate is about 300 mg.

13 . The solid oral pharmaceutical tablet according to claim 1 , wherein the tablet has a median Tmax of meloxicam that is less than about 90 minutes in a human subject under fasting conditions.

14 . The solid oral pharmaceutical tablet according to claim 1 , wherein the tablet has a median Tmax of meloxicam that is less than about 60 minutes in a human subject under fasting conditions.

15 . A solid oral pharmaceutical tablet comprising amorphous meloxicam and at least one pharmaceutically acceptable excipient, wherein the amorphous meloxicam is embedded in alkaline surroundings comprising one or more water-soluble alkalizing agents, and wherein the tablet provides a plasma concentration (Cmax) of meloxicam that is between about 2000 ng/ml to about 3500 ng/ml.

16 . The solid oral pharmaceutical tablet according to claim 15 , wherein the Cmax of meloxicam is between about 2200 ng/ml to about 3400 ng/ml.

17 . The oral tablet of claim 15 , wherein the amount of meloxicam in the tablet is about 15 mg.

18 . The oral tablet of claim 17 , comprising a hydrophilic polymer or polymers selected from copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose, PEG 6000, PEG 8000, or PEG 20000, and combinations thereof.

19 . The solid oral pharmaceutical tablet of claim 15 , wherein the one or more pharmaceutically acceptable excipients comprise a diluent, lubricant, glidant, disintegrant, or binder, or any combination thereof.

20 . The solid oral pharmaceutical tablet of claim 19 , wherein the one or more pharmaceutically acceptable excipients comprise at least a lubricant.

21 . The oral tablet of claim 19 , wherein the excipients comprise magnesium stearate and crospovidone.

22 . The solid oral pharmaceutical tablet of claim 15 , wherein the water-soluble alkalizing agent is present in an amount of less than 400 mg.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 6, 2024
From: PATIL, PANKAJ DEVIDAS; KHYAMGONDE, VIVEKANAND; KAKARIA, RITESH; JAISWAL, ASHISH; DIXIT, AKHILESH; CHAKRABORTY, SANTANU; ANTARKAR, AMIT; DESHMUKH, ABHIJIT; SMITH, JEFFREY P.
To: MYLAN LABORATORIES LTD
Reel/Frame 066392/0181 →
Priority Claims (1)
IN 202041048559 · Nov 6, 2020 · national
Continuity (1)
Related Publication 20240277726A1 · Aug 22, 2024
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